Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score

NCT07681583 | Recruiting

• 1 other identifier: CEAVC 29602
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The FUNGAL-P study is a single-center observational study designed to derive and validate a clinical prediction score for the early identification of fungal pneumonia in adult patients presenting with pneumonia. The study includes a retrospective derivation cohort and a prospective validation cohort of patients undergoing microbiological evaluation of lower respiratory tract samples. Clinical, laboratory, radiological, microbiological, and treatment-related variables associated with fungal pneumonia will be analyzed to identify independent predictors of fungal infection. These predictors will be combined to develop the FUNGAL-P score. The derived score will subsequently be evaluated in a prospective validation cohort to assess its diagnostic performance, calibration, and clinical utility. The ultimate goal is to facilitate earlier recognition of fungal pneumonia and support timely diagnostic testing and antifungal treatment in patients presenting to the Emergency Department or hospital with pneumonia.

Conditions

Fungal Pneumonia; Pulmonary Aspergillosis; Pneumocystis; Pneumocystis Pneumonia; Fungal Disease; Fungal Infection; Fungal Infection Lungs; Pneumonia; Aspergillosis Pneumonia; Pulmonary Aspergillosis Invasive

Keywords

Fungal Pneumonia; Aspergillus; Pulmonary Aspergillosis; Pneumocystis jirovecii; Pneumocystis Pneumonia; Coinfection; Community-Acquired Pneumonia; CAP; Risk Prediction; Clinical Prediction Rule; Clinical Risk Score; FUNGAL-P Score; SCORE; Bronchoalveolar Lavage; Emergency Department; Internal medicine; Infectious disease; Diagnostic Accuracy; Risk Factors; Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score

  Evaluation of the discriminative ability of the FUNGAL-P score for identifying fungal pneumonia.

  At completion of study analysis (30 days)

Secondary Outcomes (4)

• Area under the receiver operating characteristic curve (AUROC) of the FUNGAL-P score

  At completion of study analysis (30 days)

• Sensitivity and specificity of the FUNGAL-P score

  At completion of study analysis (30 days)

• Calibration of the FUNGAL-P score

  At completion of study analysis (30 days)

• Clinical utility of the FUNGAL-P score

  At completion of study analysis (30 days)

Study Arms (2)

Retrospective Derivation Cohort

Adult patients with microbiologically confirmed pneumonia enrolled at Careggi University Hospital between January 1, 2022 and December 31, 2023. Clinical, laboratory, radiological, microbiological, treatment, and outcome data were collected to identify independent predictors of fungal pneumonia and to derive the FUNGAL-P clinical prediction score.

Other: FUNGAL-P Score Assessment

Prospective Validation Cohort

Consecutive adult patients with pneumonia enrolled at Careggi University Hospital between 13 nov, 2025 and December 31, 2030. The cohort was used to prospectively evaluate the diagnostic performance, calibration, and clinical utility of the derived FUNGAL-P score without influencing clinical management.

Other: FUNGAL-P Score Assessment

Interventions

FUNGAL-P Score Assessment OTHER

Observational assessment of clinical, laboratory, radiological, and microbiological variables used to derive and validate the FUNGAL-P clinical prediction score for fungal pneumonia. No study-specific intervention was performed and patient management was not influenced by the study.

Prospective Validation Cohort; Retrospective Derivation Cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting with pneumonia at Careggi University Hospital who underwent microbiological evaluation of lower respiratory tract samples, including bronchoalveolar lavage, bronchial aspirate, or endotracheal aspirate, within 48 hours of hospital presentation. The study population includes patients with microbiologically confirmed fungal, bacterial, or viral pneumonia enrolled in retrospective and prospective cohorts for derivation and validation of the FUNGAL-P clinical prediction score.

You may qualify if:

• Age ≥18 years and ≤90 years.
• Presentation to the Emergency Department or hospital with pneumonia.
• Pneumonia defined according to IDSA/ATS criteria as the presence of at least two clinical signs or symptoms of lower respiratory tract infection (temperature \<36.0°C or \>38.0°C, respiratory rate \>20 breaths/min, oxygen saturation \<90% on room air, arterial PaO₂ \<60 mmHg, cough, sputum production, white blood cell count \<4,000/μL or \>10,000/μL, or bandemia \>10%) together with radiographic evidence of a new pulmonary infiltrate or cavitary lesion.
• Bronchoalveolar lavage (BAL), bronchial aspirate (BAS), or endotracheal aspirate (ETA) performed within 48 hours of hospital presentation.
• Modified Rankin Scale score \<5.
• Availability of microbiological investigations for identification of fungal, bacterial, or viral pathogens.
• Provision of informed consent, when required by applicable regulations and ethics committee approval.

You may not qualify if:

• Refusal or withdrawal of informed consent.
• Age \<18 years or \>90 years.
• Pregnancy.
• Expected life expectancy \<3 months.
• Hospital-acquired pneumonia with onset \>48 hours after hospital admission.
• Modified Rankin Scale score ≥5.
• Absence of microbiological diagnostic evaluation.
• No identified bacterial, fungal, or viral pathogen after microbiological investigations.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Careggi University Hospital

Florence, Italy

RECRUITING

Related Publications (1)

• 1. Esandi M, Magnasco L, Farina EC, et al. Early diagnosis of candidiasis in non-neutropenic critically ill patients: prospective study. Intensive Care Med. 2003;29(9):1534-1540. doi:10.1007/s00134-003-1825-3 2. Wang K, Wang Y, Liu M, et al. Retrospective evaluation of risk factors for invasive Candida infections in a medical ICU. Medicine (Baltimore). 2024;103(14):e38338. doi:10.1097/MD.0000000000038338 3. Kullberg BJ, Arendrup MC. Invasive candidiasis. N Engl J Med. 2015;373(15):1445-1456. doi:10.1056/NEJMra1315399 4. Playford EG, Eggimann P, Calandra T, et al. Epidemiology of invasive candidiasis in non-neutropenic critically ill patients. Lancet Infect Dis. 2010;10(12):775-784. doi:10.1016/S1473-3099(10)70267-7 5. Leroy G, Lambiotte F, Thévenin D, et al. Risk factors of invasive fungal disease in critically ill adult patients: a systematic review. Crit Care. 2012;16(5):R242. doi:10.1186/cc11844 6. Aguilar C, Kumar D, Humar A, et al. Risk factors for invasive fungal infections in lung transplant recipients: a systematic review and meta-analysis. Clin Transplant. 2021;35(4):e14232. doi:10.1111/ctr.14232 7. Li Y, Wang J, Zhang H, et al. A novel scoring system to predict invasive candidiasis in immunocompetent critically ill patients. Front Microbiol. 2023;14:1097574. doi:10.3389/fmicb.2023.1097574 8. Bougnoux ME, Kac G, Aegerter P, et al. Candidemia and Candida colonization in critically ill patients: incidence and risk factors. Intensive Care Med. 2008;34(11):1955-1961. doi:10.1007/s00134-008-1197-4 9. Bassetti M, Righi E, Ansaldi F, et al. A multicenter study of candidemia in intensive care units in Italy. Intensive Care Med. 2006;32(10):1523-1529. doi:10.1007/s00134-006-0298-8 10. Blot SI, Taccone FS, Van den Abeele AM, et al. A clinical algorithm to diagnose invasive pulmonary aspergillosis in critically ill patients. Intensive Care Med. 2012;38(9):1294-1303. doi:10.1007/s00134-012-2600-5 11. Lu LY, Cheng Y, Wang H, et al. Risk factors and outcomes of influenza

  BACKGROUND

MeSH Terms

Conditions

Pneumonia; Pulmonary Aspergillosis; Invasive Pulmonary Aspergillosis; Pneumonia, Pneumocystis; Mycoses; Coinfection; Community-Acquired Pneumonia; Emergencies; Communicable Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Lung Diseases; Respiratory Tract Diseases; Aspergillosis; Bacterial Infections and Mycoses; Lung Diseases, Fungal; Invasive Fungal Infections; Pneumocystis Infections; Community-Acquired Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lorenzo Pelagatti, MD, PhD

  University of Florence

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Pelagatti, MD, PhDs

CONTACT

+39 3385917317; pelagattil@aou-careggi.toscana.it

Peiman Nazerian, MD

CONTACT

nazierianp@aou-careggi.toscana.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: November 13, 2025
• Primary Completion (Estimated): November 13, 2030
• Study Completion (Estimated): November 13, 2031
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

IT (1)